"the pharmaprofile"; towards tailor-made pharmacotherapy for the terminally ill adult patient.

"the pharmaprofile"; towards tailor-made pharmacotherapy for the terminally ill adult patient. - Pharmaprofile terminally ill adult

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34339

Enrollment

150

Registered

2012-02-10

Start date

2012-02-20

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

palliatieve zorg, terminale ziekte comfort palliative sedation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Terminal illness -Prognosis survival more than 2 days and less than 3 months -Administration of morphine, haloperidol and/or midazolam -Informed consent

Exclusion criteria

Exclusion criteria: -Withdrawal of informed consent -No blood sample obtained

Design outcomes

Primary

Measure	Time frame
The development of a population pharmacokinetic-pharmacodynamic model for morphine, haloperidol and midazolam for terminally ill patients. For each patient a pharmaprofile will be constructed contain information regarding co-morbidity, co-medication, nutritional status, laboratory results, demographic and pathophysiological factors. Pharmacokinetics parameters will be estimated in small samples of blood and urine using the LC-MS technique and analysis by NONMEM-software. NONMEM allows the use of limited numbers of samples/observations and sparse sampling strategies without fixed protocol times. Clinical responses will be monitored with objective and validated instruments for pain, confusion, sedation, nausea/vomiting, dyspnoea and fatigue to estimate pharmacodynamic parameters.	—

Measure

Time frame

The development of a population pharmacokinetic-pharmacodynamic model for morphine, haloperidol and midazolam for terminally ill patients. For each patient a pharmaprofile will be constructed contain information regarding co-morbidity, co-medication, nutritional status, laboratory results, demographic and pathophysiological factors. Pharmacokinetics parameters will be estimated in small samples of blood and urine using the LC-MS technique and analysis by NONMEM-software. NONMEM allows the use of limited numbers of samples/observations and sparse sampling strategies without fixed protocol times. Clinical responses will be monitored with objective and validated instruments for pain, confusion, sedation, nausea/vomiting, dyspnoea and fatigue to estimate pharmacodynamic parameters.

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Countries

Netherlands

Outcome results